Cleared Traditional

K952421 - NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS

K952421 is an FDA 510(k) clearance for NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULA..., manufactured by American Hydro-Surgical Instruments, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K952421 · American Hydro-Surgical Instruments, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
16d
Days
Class 2
Risk

K952421 is an FDA 510(k) clearance for the NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by American Hydro-Surgical Instruments, Inc. (Delray Beach, US). The FDA issued a Cleared decision on June 8, 1995 after a review of 16 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 American Hydro-Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K952421

510(k) Number K952421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1995
Decision Date June 08, 1995
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
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 858
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K952421.
ETHICON ARTHROSCOPIC KNOT PUSHER
K952814 · Ethicon, Inc. · Jul 1995
ENDOPATH AND PROXIMATE LINEAR CUTTERS AND STAPLERS
K951546 · Ethicon Endo-Surgery, Inc. · Jun 1995
INSULATED ELECTROSURGICAL INSTRUMENTS
K951986 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
NEXHAT-DORSEY PENCIL-GRIP TRUMPET VALVE WITH CUTTING AND COAGULATION HAND CONTROLS
K951733 · American Hydro-Surgical Instruments, Inc. · May 1995
LAPAROSCOPIC CLAMP
K950702 · Applied Medical Resources · May 1995
KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
K951625 · KARL STORZ Endoscopy-America, Inc. · May 1995