Cleared Traditional

K951490 - LASEVAC

K951490 is an FDA 510(k) clearance for LASEVAC, manufactured by D.D. Surgical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K951490 · D.D. Surgical, Inc. · Obstetrics & Gynecology device
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Jun 1995
Decision
74d
Days
Class 2
Risk

K951490 is an FDA 510(k) clearance for the LASEVAC. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by D.D. Surgical, Inc. (Easton, US). The FDA issued a Cleared decision on June 13, 1995 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology 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 D.D. Surgical, Inc. devices

FDA 510(k) Submission Details - K951490

510(k) Number K951490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1995
Decision Date June 13, 1995
Days to Decision 74 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 160d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 228
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K951490.
KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
K950962 · KARL STORZ Endoscopy-America, Inc. · Jul 1995
NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)
K946380 · American Hydro-Surgical Instruments, Inc. · Jul 1995
KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE
K951190 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
KSE STEINER ELECTROMECHANIC MORCELLATOR
K946147 · KARL STORZ Endoscopy-America, Inc. · May 1995
KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS
K946359 · KARL STORZ Endoscopy-America, Inc. · May 1995
KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS
K945685 · KARL STORZ Endoscopy-America, Inc. · May 1995