Chrysalis Intelligence · Product Codes · NEW

NEW · Unclassified

18 clearances · 10 unique sponsors

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals

Device class

—

Regulation —

Total clearances

18

2020-03-25 → 2026-07-09

Last 12 months

7

Unique sponsors

10

Classification details

Medical specialty

—

Review panel

—

Regulation number

—

Implant

—

Life-sustain / support

—

GMP exempt

—

Third-party review

—

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
ETHICON, Inc.	4	2	2026-05-18
Hans Biomed Corporation	2	0	2023-03-07
M/s. Meril Endo Surgery Private Limited.	2	1	2025-09-23
Feeltech Co., Ltd.	2	2	2025-10-20
Suturion AB	2	0	2025-04-28
Hyundae Meditech Co., Ltd.	2	0	2024-09-27
Sutura Medical Technology, Inc.	1	1	2026-06-12
Foosin Medical Supplies Inc., Ltd.	1	0	2020-10-20
Pdo Max, Inc.	1	0	2021-12-17
Teleflex Medical, LLC	1	1	2026-07-09

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
A4261	HCPCS	Cervical cap for contraceptive use ✓ CMS-verified description	High	Surgical sutures, absorbable (e.g., polydioxanone)

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-09	K261988	Teleflex Medical, LLC	Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture
2026-06-12	K252171	Sutura Medical Technology, Inc.	Barbed PDO Suture
2026-05-18	K252047	ETHICON, Inc.	STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices
2025-11-12	K243897	ETHICON, Inc.	PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
2025-10-20	K251414	Feeltech Co., Ltd.	Miracu Polydioxanone (PDO) Suture and Needle (MONO)
2025-10-15	K250107	Feeltech Co., Ltd.	V-soft Line Barbed Surgical Suture (Various)
2025-09-23	K252644	M/s. Meril Endo Surgery Private Limited.	PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture
2025-04-28	K250977	Suturion AB	Suture-TOOL System
2025-01-22	K242835	Suturion AB	Suture-TOOL System
2024-09-27	K242571	Hyundae Meditech Co., Ltd.	Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938
2024-04-25	K232246	M/s. Meril Endo Surgery Private Limited.	1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture
2024-03-27	K240389	Hyundae Meditech Co., Ltd.	Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)
2023-03-07	K220549	Hans Biomed Corporation	MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014
2022-02-22	K212380	ETHICON, Inc.	PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
2021-12-17	K210871	Pdo Max, Inc.	PDO Max Suture with Dual Needle
2020-10-20	K201139	Foosin Medical Supplies Inc., Ltd.	WEGO-PDO Barbed Suture
2020-09-09	K192423	Hans Biomed Corporation	MINT Product Family
2020-03-25	K192144	ETHICON, Inc.	STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device