Cleared Traditional

K961616 - TELESCOPING PENEVAC (MODIFICATION)

K961616 is the FDA 510(k) clearance for TELESCOPING PENEVAC (MODIFICATION) by I.C Medical, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K961616 · I.C Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
36d
Days
Class 2
Risk

K961616 is an FDA 510(k) clearance for the TELESCOPING PENEVAC (MODIFICATION). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by I.C Medical, Inc. (Glendale, US). The FDA issued a Cleared decision on May 28, 1996 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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 I.C Medical, Inc. devices

Submission Details

510(k) Number K961616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1996
Decision Date May 28, 1996
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 893
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K961616.
SELECTONE UNIVERSAL PLUS MUNRO LAPAROSCOPIC LOOP ELECTRODE MODEL 60-5276 SERIES
K961197 · Conmedcorp · Jun 1996
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K962030 · KARL STORZ Endoscopy-America, Inc. · Jun 1996
ELECTROSURGICAL AND ARTHROSCOPY ACCESSORY ELECTRODES
K961812 · Conmedcorp · Jun 1996
ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE
K960476 · Ethicon, Inc. · Apr 1996
CONMED SELECT ONE LAPAROSCOPY ELECTRODE
K960808 · Conmedcorp · Mar 1996
STORZ S2050 SERIES BIPOLAR FORCEPS
K960009 · Storz Instrument Co. · Mar 1996