Cleared Traditional

MANUAL SURGICAL INSTRUMENTS (K921925) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921925 · 3M Health Care, Ltd. · General & Plastic Surgery device
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May 1993
Decision
397d
Days
Class 2
Risk

K921925 is an FDA 510(k) clearance for the MANUAL SURGICAL INSTRUMENTS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on May 26, 1993 after a review of 397 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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. Elevated predicate reliance profile. 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 3M Health Care, Ltd. devices

Submission Details

510(k) Number K921925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1992
Decision Date May 26, 1993
Days to Decision 397 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
282d slower than avg
Panel avg: 115d · This submission: 397d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GCJ Laparoscope, General & Plastic Surgery

All 399
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K921925.
ENDOPATH ENDOSCOPIC SURGICAL INSTRUMENTS
K930933 · Ethicon, Inc. · Jun 1993
ENDOPATH* DISPOSABLE INTRODUCER
K931237 · Ethicon, Inc. · Jun 1993
ENDOPATH DISPOSABLE KNOT PUSHER
K931238 · Ethicon, Inc. · Jun 1993
PRE-TIED LOOP SUTURE CANNULA
K925914 · Ethicon, Inc. · May 1993
GUIDE WIRE FOR LAPOROSCOPIC USE
K926214 · Terumo Medical Corp. · Apr 1993
AUTO SUTURE DILATING CANNULA
K931337 · United States Surgical, A Division of Tyco Healthc · Apr 1993