Cleared Traditional

K922186 - HEM-O-LOK -- MODIFICATION

K922186 is the FDA 510(k) clearance for HEM-O-LOK -- MODIFICATION by Linvatec Corp.. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K922186 · Linvatec Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
161d
Days
Class 2
Risk

K922186 is an FDA 510(k) clearance for the HEM-O-LOK -- MODIFICATION. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Linvatec Corp. (Research Triangle Pa, US). The FDA issued a Cleared decision on August 6, 1992 after a review of 161 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Linvatec Corp. devices

Submission Details

510(k) Number K922186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1992
Decision Date August 06, 1992
Days to Decision 161 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 115d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GDW Staple, Implantable

All 157
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K922186.
SURGICAL STAPLE
K942606 · United States Surgical, A Division of Tyco Healthc · Aug 1994
STRYKER STAPLER SYSTEM
K931103 · Stryker Endoscopy · Oct 1993
ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER
K920752 · Ethicon, Inc. · Aug 1992
3M PRECISE BRAND INTERNAL SURGICAL STAPLES
K921051 · 3M Health Care, Ltd. · Jul 1992
PROXIMATE ABSORBABLE STAPLES
K915693 · Ethicon, Inc. · Mar 1992
AUTO SUTURE ABSORABLE SUBCUTICULAR CLOSURE STAPLE
K915489 · United States Surgical, A Division of Tyco Healthc · Jan 1992