Chrysalis Intelligence · Sponsors · Microline Surgical, Inc.

Microline Surgical, Inc.

Beverly, MA, US · 3 510(k) clearances · 1 recalls

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Total clearances

3

2020-10-21 → 2024-04-23

Last 12 months

0

Product codes

1

Most recent

2024-04-23

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
GEI	Electrosurgical, Cutting & Coagulation & Accessories	Class II	General, Plastic Surgery	3	2024-04-23

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

1

Most recent

2024-11-05

Date	Severity	Status	Recall #	Product	Code	Reason
2024-11-05	Class II	Ongoing	Z-0663-2025	Microscissor Tip (Disposable); Microline Catalog #: 3122.	—	A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.

Filings

All 510(k) clearances (3)

Date	K-number	Device	Code	Class	Specialty
2024-04-23	K234147	ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)	GEI	Class II	General, Plastic Surgery
2022-03-02	K213127	ReNew Disposable Scissor Tips	GEI	Class II	General, Plastic Surgery
2020-10-21	K201884	ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm	GEI	Class II	General, Plastic Surgery