Chrysalis Intelligence · Product Codes · MPN

MPN · Tissue Adhesive For The Topical Approximation Of Skin

General, Plastic Surgery · 8 clearances · 6 unique sponsors

Device class
Class II
Regulation 878.4010
Total clearances
8
2020-03-09 → 2025-09-19
Last 12 months
1
Unique sponsors
6
Definition

What is Tissue Adhesive For The Topical Approximation Of Skin

Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).
Medical specialty
General, Plastic Surgery
Review panel
SU
Regulation number
878.4010
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Okapi Medical, LLC Dba Resivant Medical 2 0 2025-08-04
Chemence Medical, Inc. 2 0 2021-09-09
Connexicon Medical , Ltd. 1 0 2024-07-15
M/s. Meril Endo Surgery Private Limited. 1 0 2024-03-16
Optmed, Inc. 1 1 2025-09-19
Advanced Medical Solutions Limited 1 0 2020-03-09
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.

CodeTypeDescriptionConfidenceRationale
66680 CPT Low Repair of laceration; conjunctiva, with or without simple subconjunctival laceration
G0168 HCPCS Wound closure utilizing tissue adhesive(s) only ✓ CMS-verified description Low Tissue adhesive (e.g., fibrin glue), topical application
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-09-19 K243990 Optmed, Inc. BondEase 2 Topical Skin Adhesive
2025-08-04 K250950 Okapi Medical, LLC Dba Resivant Medical CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)
2024-08-20 K234114 Okapi Medical, LLC Dba Resivant Medical CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)
2024-07-15 K233458 Connexicon Medical , Ltd. CM005 Standard (CM005); CM004 Mini (CM004)
2024-03-16 K230981 M/s. Meril Endo Surgery Private Limited. Meriglu Topical Skin Adhesive
2021-09-09 K212246 Chemence Medical, Inc. Exofin Precision Pen
2020-12-17 K200264 Chemence Medical, Inc. Exofin High Viscosity Topical Skin Adhesive
2020-03-09 K183570 Advanced Medical Solutions Limited LiquiBand Plus