Cleared Traditional

HOLMED HAND HELD INSTRUMENTS (K913810) - FDA 510(k) Clearance

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

K913810 · Performance Surgical Instruments Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
115d
Days
Class 2
Risk

K913810 is an FDA 510(k) clearance for the HOLMED HAND HELD INSTRUMENTS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Performance Surgical Instruments Corp. (Holbrook, US). The FDA issued a Cleared decision on December 19, 1991 after a review of 115 days - within the typical 510(k) review window.

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. 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 Performance Surgical Instruments Corp. devices

Submission Details

510(k) Number K913810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1991
Decision Date December 19, 1991
Days to Decision 115 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 115d · This submission: 115d
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 K913810.
ENDOPATH ENDOS LINEAR CUT W/SAF LOCK-OUT/RELOAD UN
K915099 · Ethicon, Inc. · Mar 1992
LAPAROSCOPY SCISSORS
K915544 · C.R. Bard, Inc. · Mar 1992
ENDOPATH DISPOSABLE TROCAR SLEEVE W/DILATING OBTUR
K915239 · Ethicon, Inc. · Jan 1992
ETHICON ABSORBABLE SUTURE CLIP AND APPLIER
K914549 · Ethicon, Inc. · Dec 1991
PNEUMO-SEAL(TM)
K914470 · Edward Weck, Inc. · Nov 1991
LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM
K914547 · Baxter Healthcare Corp · Nov 1991