Cleared Traditional

K992996 - ENABLE ENDOSCOPIC BIPOLAR SCISSORS

K992996 is an FDA 510(k) clearance for ENABLE ENDOSCOPIC BIPOLAR SCISSORS, manufactured by Enable Medical Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K992996 · Enable Medical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
78d
Days
Class 2
Risk

K992996 is an FDA 510(k) clearance for the ENABLE ENDOSCOPIC BIPOLAR SCISSORS. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Enable Medical Corp. (West Chester, US). The FDA issued a Cleared decision on November 24, 1999 after a review of 78 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.

FDA 510(k) Submission Details - K992996

510(k) Number K992996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1999
Decision Date November 24, 1999
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

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 2203
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K992996.
XOMED ENT RF SYSTEM
K993112 · Xomed, Inc. · Dec 1999
ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES
K993854 · Oratec Interventions, Inc. · Dec 1999
RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE
K993944 · Rita Medical Systems · Dec 1999
NON-STICK BIPOLAR FORCEPS
K992931 · Silverglide Surgical Technologies · Nov 1999
UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F
K993647 · Unimed Surgical Products, Inc. · Nov 1999
TUBULAR ELECTRODE DEVICE
K992542 · Conway Stuart Medical, Inc. · Oct 1999
K992996 · ENABLE ENDOSCOPIC BIPOLAR SCISSORS
Download PDF FDA Summary Enable Medical Corp.