Cleared Traditional

PSB PREPERITONEAL STRUCTURE BALLOON (K942636) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K942636 · Origin Medsystems, Inc. · Ophthalmic device
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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

Submission Details

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
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.

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 Ophthalmic devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 399
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K942636.
OLYMPUS SUPERVIEW LAPAROSCOPE FOR GENERAL SURGERY
K942839 · Olympus America, Inc. · Jul 1994
AESCULAP FLEXIBLE TROCAR INSTRUMENT SET
K935243 · Aesculap, Inc. · Jul 1994
ANGLED DISSECTORS MODELS 8383.581/582/571
K940948 · Richard Wolf Medical Instruments Corp. · Jul 1994
AESCULAP INTERCHANGEABLE TROCAR INSTRUMENT SET
K942053 · Aesculap, Inc. · Jun 1994
AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS
K933330 · Aesculap, Inc. · Jun 1994
KNOT SLIDE 8383.55 AND 8383.551
K941136 · Richard Wolf Medical Instruments Corp. · Jun 1994