Cleared Traditional

K942636 - PSB PREPERITONEAL STRUCTURE BALLOON

K942636 is an FDA 510(k) clearance for PSB PREPERITONEAL STRUCTURE BALLOON, manufactured by Origin Medsystems, Inc.. The device is a Class 2 Ophthalmic device with product code GCJ cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K942636 · Origin Medsystems, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
28d
Days
Class 2
Risk

K942636 is an FDA 510(k) clearance for the PSB PREPERITONEAL STRUCTURE BALLOON. 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 1, 1994 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - the FDA ophthalmic 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 - K942636

510(k) Number K942636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1994
Decision Date July 01, 1994
Days to Decision 28 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 110d · This submission: 28d
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 Ophthalmic 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 K942636.
DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH
K942879 · Deroyal Industries, Inc. · Jul 1994
LIFTING DISTENTION BALLOON SYSTEM
K942678 · Origin Medsystems, Inc. · Jul 1994
ORIGIN BALLOON RETRACTOR
K942491 · 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
R-BAR RETRACTOR
K942415 · Linvatec Corp. · Jun 1994