Cleared Traditional

K772387 - LEAD HAND

K772387 is an FDA 510(k) clearance for LEAD HAND, manufactured by Edward Weck, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K772387 · Edward Weck, Inc. · General Hospital
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Apr 1978
Decision
99d
Days
Class 2
Risk

K772387 is an FDA 510(k) clearance for the LEAD HAND. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1978 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Edward Weck, Inc. devices

FDA 510(k) Submission Details - K772387

510(k) Number K772387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1977
Decision Date April 05, 1978
Days to Decision 99 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 Hospital devices follow this clearance model.

Regulatory Peers - KKX Drape, Surgical

All 167
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K772387.
OP-SITE ADHESIVE DRAPES
K780853 · Acme United Corp. · Aug 1978
BARRIER GYNECOLOGY PACK FABRIC 450
K780856 · Surgikos, Inc. · Aug 1978
DRAPING MATERIAL, COLBALT 60 STERILE
K780846 · Kimberly-Clark Corp. · Jun 1978
TOWEL, DRAPE, BOUNDARY
K780036 · Procter & Gamble Mfg. Co. · Jan 1978
SHAVE PREP TRAY
K771036 · Parke-Davis Co. · Jul 1977
HYPERALIMENTATION TRAY
K771050 · American Hospital Supply Corp. · Jul 1977