Cleared Traditional

K942491 - ORIGIN BALLOON RETRACTOR

K942491 is an FDA 510(k) clearance for ORIGIN 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 43-day FDA review.

K942491 · Origin Medsystems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
43d
Days
Class 2
Risk

K942491 is an FDA 510(k) clearance for the ORIGIN BALLOON RETRACTOR. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Origin Medsystems, Inc. (Menlo Park, US). The FDA issued a Cleared decision on July 7, 1994 after a review of 43 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 - K942491

510(k) Number K942491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1994
Decision Date July 07, 1994
Days to Decision 43 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
72d faster than avg
Panel avg: 115d · This submission: 43d
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 K942491.
ANGLED DISSECTORS MODELS 8383.581/582/571
K940948 · Richard Wolf Medical Instruments Corp. · Jul 1994
DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH
K942879 · Deroyal Industries, Inc. · Jul 1994
LIFTING DISTENTION BALLOON SYSTEM
K942678 · Origin Medsystems, Inc. · Jul 1994
PSB PREPERITONEAL STRUCTURE BALLOON
K942636 · Origin Medsystems, Inc. · Jul 1994
STRYKER ARTHROSCOPIC ACCESSORIES
K930224 · Stryker Corp. · Jun 1994
TROCAR SLEEVE, SEALING CAPS, REDUCER, LOOP GUIDE
K942414 · Linvatec Corp. · Jun 1994