Cleared Traditional

K844608 - SURGICRAFT COPELAND DISPOSABLE

K844608 is an FDA 510(k) clearance for SURGICRAFT COPELAND DISPOSABLE, manufactured by A.W. Showell (Surgicraft) , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGP cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K844608 · A.W. Showell (Surgicraft) , Ltd. · Obstetrics & Gynecology device
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May 1985
Decision
155d
Days
Class 2
Risk

K844608 is an FDA 510(k) clearance for the SURGICRAFT COPELAND DISPOSABLE. Classified as Electrode, Circular (spiral), Scalp And Applicator (product code HGP), Class II - Special Controls.

Submitted by A.W. Showell (Surgicraft) , Ltd. (Worcs. B97 6hf England, GB). The FDA issued a Cleared decision on May 1, 1985 after a review of 155 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2675 - 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 A.W. Showell (Surgicraft) , Ltd. devices

FDA 510(k) Submission Details - K844608

510(k) Number K844608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1984
Decision Date May 01, 1985
Days to Decision 155 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
5d faster than avg
Panel avg: 160d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGP Device Classification - Class 2, Special Controls

Product Code HGP Electrode, Circular (spiral), Scalp And Applicator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2675
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 - HGP Electrode, Circular (spiral), Scalp And Applicator

All 8
Devices cleared under the same product code (HGP) and FDA review panel - the closest regulatory comparables to K844608.
COMBO FETAL SCALP ELECTRODE/LEGPLATE
K905830 · Utah Medical Products, Inc. · Mar 1991
MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE
K904745 · Graphic Controls Corp. · Jan 1991
FETAL MONITORING SPIRAL ELECTRODE
K905130 · Graphic Controls Corp. · Jan 1991
MULTI-PRONG FETAL SCALP ELECTRODE
K822584 · Kontron Instruments, Inc. · Feb 1983
COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE
K792669 · Ge Medical Systems Information Technologies · Feb 1980
SPIRAL SCALP ELECTRODE, 14499A
K771553 · Hewlett-Packard Co. · Aug 1977