Cleared Traditional

K914203 - LAPAROSCOPIC BALLOON RETRACTOR

K914203 is an FDA 510(k) clearance for LAPAROSCOPIC BALLOON RETRACTOR, manufactured by Origin Medsystems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K914203 · Origin Medsystems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
20d
Days
Class 2
Risk

K914203 is an FDA 510(k) clearance for the LAPAROSCOPIC BALLOON RETRACTOR. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Origin Medsystems, Inc. (San Carlos, US). The FDA issued a Cleared decision on October 9, 1991 after a review of 20 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 Origin Medsystems, Inc. devices

FDA 510(k) Submission Details - K914203

510(k) Number K914203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1991
Decision Date October 09, 1991
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
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 723
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K914203.
MONOSCOPY(TM) BRAND, ENDOBAG
K913762 · Dexide, Inc. · Oct 1991
EVACUATION/IRRIGATION/ELECROSURGICAL DEVICE
K912492 · Ethicon, Inc. · Oct 1991
MEDICAM LAPAROSCOPY ENDOSCOPES
K912933 · Kirschner Medical Corp. · Oct 1991
GRASPER, RATCHETED (5MM X 30CM)
K913991 · Northgate Technologies, 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