Cleared Traditional

K921925 - MANUAL SURGICAL INSTRUMENTS

K921925 is an FDA 510(k) clearance for MANUAL SURGICAL INSTRUMENTS, manufactured by 3M Health Care, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 397-day FDA review.

K921925 · 3M Health Care, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K921925

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
Combination Product No
PCCP Authorized No
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.

GCJ Device Classification - Class 2, Special Controls

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 1128
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K921925.
ENDOPATH II DISPOSABLE SURGICAL TROCAR & SLEEVE
K932282 · Ethicon Endo-Surgery, Inc. · Jun 1993
ENDOSCOPIC OR THORASCOPIC FORCEPS
K931259 · T. Korossurgical Instruments Corp. · Jun 1993
BLUNT DISSECTING SCISSORS
K930464 · Surgical Technologies, Inc. · Jun 1993
WIRE GUIDED OVAL DILATORS
K930465 · Surgical Technologies, Inc. · May 1993
COMPRESSION CLAMP
K930466 · Surgical Technologies, Inc. · May 1993
BABCOCK FORCEPS, GRASPING FORCEPS, NEEDLE HOLDER
K930467 · Surgical Technologies, Inc. · May 1993