Cleared Traditional

K954088 - TELESCOPING PENEVAC

K954088 is the FDA 510(k) clearance for TELESCOPING PENEVAC 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 22-day FDA review.

K954088 · I.C Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
22d
Days
Class 2
Risk

K954088 is an FDA 510(k) clearance for the TELESCOPING PENEVAC. 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 September 22, 1995 after a review of 22 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 K954088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1995
Decision Date September 22, 1995
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
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 K954088.
AESCULAP BIPOLAR CORDS
K953446 · Aesculap, Inc. · Sep 1995
UNIVERSAL PLUS ES S/I INSTRUMENT
K954056 · Conmedcorp · Sep 1995
BIPOLAR GENERATOR MODEL 2352
K945914 · Richard Wolf Medical Instruments Corp. · Sep 1995
TAKE-APART SCISSORS
K954122 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
VL7600 REM PATIENT RETURN ELECTRODE
K953737 · Valleylab, Inc. · Aug 1995
VALLEYLAB FORCE 300
K953195 · Valleylab, Inc. · Aug 1995