Cleared Traditional

K781949 - ELECTROSURGERY MODEL 771

K781949 is an FDA 510(k) clearance for ELECTROSURGERY MODEL 771, manufactured by Birtcher Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K781949 · Birtcher Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1979
Decision
97d
Days
Class 2
Risk

K781949 is an FDA 510(k) clearance for the ELECTROSURGERY MODEL 771. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Birtcher Corp. (Mchenry, US). The FDA issued a Cleared decision on February 26, 1979 after a review of 97 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 Birtcher Corp. devices

FDA 510(k) Submission Details - K781949

510(k) Number K781949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1978
Decision Date February 26, 1979
Days to Decision 97 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 115d · This submission: 97d
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 1259
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K781949.
ELECTRODE, MODEL E7504 PREP II
K790296 · Valleylab, Inc. · Apr 1979
GRAB-IT
K790367 · Concept, Inc. · Mar 1979
BOVIE HAND CONTROL
K790187 · Sybron Corp. · Feb 1979
DISPOSABLE LECTROSWITCH, MODEL E2503
K781510 · Valleylab, Inc. · Oct 1978
LECTROSWITCH MODEL E2502B
K781511 · Valleylab, Inc. · Oct 1978
HAND-TROL CONNECTOR EXTENDER
K781429 · Aspen Laboratories, Inc. · Aug 1978