Cleared Traditional

LAP TISSUE COLLECTION BAG (K915286) - FDA 510(k) Clearance

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

K915286 · Baxter Healthcare Corp · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 1992
Decision
133d
Days
Class 2
Risk

K915286 is an FDA 510(k) clearance for the LAP TISSUE COLLECTION BAG. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on April 6, 1992 after a review of 133 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K915286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1991
Decision Date April 06, 1992
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
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 353
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K915286.
AUTO SUTURE ENDOSCOPIC KNOT PUSHER
K925149 · United States Surgical, A Division of Tyco Healthc · Jan 1993
AUTO SUTURE ENDOSCOPIC MINI-RETRACTOR
K920068 · United States Surgical, A Division of Tyco Healthc · Sep 1992
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC SCISSORS
K914752 · United States Surgical, A Division of Tyco Healthc · Jun 1992
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