Cleared Traditional

K920549 - SHARPE ENDONEEDLE HOLDER

K920549 is an FDA 510(k) clearance for SHARPE ENDONEEDLE HOLDER, manufactured by Paladin Medical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K920549 · Paladin Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
229d
Days
Class 2
Risk

K920549 is an FDA 510(k) clearance for the SHARPE ENDONEEDLE HOLDER. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Paladin Medical, Inc. (Stillwater, US). The FDA issued a Cleared decision on September 22, 1992 after a review of 229 days - an extended review 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: 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 Paladin Medical, Inc. devices

FDA 510(k) Submission Details - K920549

510(k) Number K920549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1992
Decision Date September 22, 1992
Days to Decision 229 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 160d · This submission: 229d
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 207
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K920549.
CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI
K924530 · Cabot Medical Corp. · Feb 1993
AUTO SUTURE SURGIPORT DISPOSABLE ANCHORING DEVICE
K915331 · United States Surgical, A Division of Tyco Healthc · Sep 1992
CONDUCTIVE SURGIGRIP SPIRAL SLEEVE
K915338 · United States Surgical, A Division of Tyco Healthc · Sep 1992
WECK TROCAR
K915378 · Edward Weck, Inc. · Jun 1992
TROCAR SHEATH ANCHOR
K915116 · Origin Medsystems, Inc. · Jun 1992
SOF-FLEX LAPAROSCOPIC BASKET
K913299 · Cook Ob/Gyn · Feb 1992