Cleared Traditional

K934800 - CONMED SELECTONE SURGICAL INSTRUMENTS

K934800 is an FDA 510(k) clearance for CONMED SELECTONE SURGICAL INSTRUMENTS, manufactured by Conmedcorp. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K934800 · Conmedcorp · General & Plastic Surgery device
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Feb 1994
Decision
133d
Days
Class 2
Risk

K934800 is an FDA 510(k) clearance for the CONMED SELECTONE SURGICAL INSTRUMENTS. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Conmedcorp (Dayton, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 133 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Conmedcorp devices

FDA 510(k) Submission Details - K934800

510(k) Number K934800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1993
Decision Date February 17, 1994
Days to Decision 133 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 115d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1271
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K934800.
ERBOTOM ICC 200
K933157 · Erbe USA, Inc. · Feb 1994
ELECTROSURGIAL INSTRUMENTS
K932654 · Medline Industries, Inc. · Feb 1994
CONMED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUNDING PADS
K934656 · Conmedcorp · Feb 1994
ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD
K934985 · KARL STORZ Endoscopy-America, Inc. · Feb 1994
VALLEYLAB MODEL E252OH, FORCE GSU(TM) HANDSET
K926481 · Valleylab, Inc. · Feb 1994
PILLING LAPAROSCOPIC INSTRUMENTATION
K934427 · Pilling Co. · Jan 1994