Cleared Traditional

LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM (K914547) - FDA 510(k) Clearance

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

K914547 · Baxter Healthcare Corp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
42d
Days
Class 2
Risk

K914547 is an FDA 510(k) clearance for the LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on November 22, 1991 after a review of 42 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K914547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1991
Decision Date November 22, 1991
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
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 K914547.
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
EVACUATION/IRRIGATION/ELECROSURGICAL DEVICE
K912492 · Ethicon, Inc. · Oct 1991
ENDOPATH DISPOSABLE ENDOSCOPIC MULTIFEED STAPLER
K913469 · Ethicon, Inc. · Sep 1991
ENDOSCOPE SUTURE & CARRIER
K912973 · United States Surgical, A Division of Tyco Healthc · Sep 1991