Cleared Traditional

K964334 - EXPANDACELL ANTI-FOG INSTRUMENT WIPE (W...

K964334 is an FDA 510(k) clearance for EXPANDACELL ANTI-FOG INSTRUMENT WIPE (W..., manufactured by Shippert Medical Technologies Corp.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K964334 · Shippert Medical Technologies Corp. · General & Plastic Surgery device
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Dec 1996
Decision
39d
Days
Class 2
Risk

K964334 is an FDA 510(k) clearance for the EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT). Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Shippert Medical Technologies Corp. (Englewood, US). The FDA issued a Cleared decision on December 9, 1996 after a review of 39 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 Shippert Medical Technologies Corp. devices

FDA 510(k) Submission Details - K964334

510(k) Number K964334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1996
Decision Date December 09, 1996
Days to Decision 39 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 115d · This submission: 39d
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 724
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K964334.
INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PERFORATING VINS ESDP, MODEL 8781
K964258 · Richard Wolf Medical Instruments Corp. · Jan 1997
NON-SHIELDED SURGICAL TROCAR AND SLEEVE
K963760 · Ethicon Endo-Surgery, Inc. · Jan 1997
OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM
K963184 · Olympus America, Inc. · Dec 1996
ENDO VIP
K963323 · Richard Wolf Medical Instruments Corp. · Nov 1996
ENDOCAM
K963046 · Corin USA · Nov 1996
ETHICON ENDOSUTURE SYSTEM
K963329 · Ethicon, Inc. · Oct 1996