Cleared Traditional

K904645 - HALL TRANSCEERVICAL SAFE ACCESS CANNULA(TM)

K904645 is an FDA 510(k) clearance for HALL TRANSCEERVICAL SAFE ACCESS CANNULA(TM), manufactured by Hall Medical Laboratories. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K904645 · Hall Medical Laboratories · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Feb 1991
Decision
138d
Days
Class 2
Risk

K904645 is an FDA 510(k) clearance for the HALL TRANSCEERVICAL SAFE ACCESS CANNULA(TM). Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Hall Medical Laboratories (Shawnee, US). The FDA issued a Cleared decision on February 26, 1991 after a review of 138 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hall Medical Laboratories devices

FDA 510(k) Submission Details - K904645

510(k) Number K904645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1990
Decision Date February 26, 1991
Days to Decision 138 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 160d · This submission: 138d
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 K904645.
FUJINON EVL-F (TENTATIVE) AND TROCAR
K902197 · Fujinon, Inc. · Mar 1991
LAPAROSCOPE
K905196 · Baxter Healthcare Corp · Mar 1991
OVARIAN ASPIRATION/IRRIGATION NEEDLE
K910579 · Marlo Surgical Technology · Feb 1991
LAPAROSCOPIC ASPIRATION PROBE
K910340 · Davol, Inc. · Feb 1991
AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE
K905426 · United States Surgical, A Division of Tyco Healthc · Feb 1991
ENDOPATH DISPOSABLE SURGICAL TROCAR REDUCER
K904907 · Ethicon, Inc. · Jan 1991