Cleared Traditional

K951912 - DISOPOSABLE & RESUABLE MONPOLAR CORD

K951912 is an FDA 510(k) clearance for DISOPOSABLE & RESUABLE MONPOLAR CORD, manufactured by Boston Surgical Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K951912 · Boston Surgical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
18d
Days
Class 2
Risk

K951912 is an FDA 510(k) clearance for the DISOPOSABLE & RESUABLE MONPOLAR CORD. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Boston Surgical Products, Inc. (Kingston, US). The FDA issued a Cleared decision on May 12, 1995 after a review of 18 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Surgical Products, Inc. devices

FDA 510(k) Submission Details - K951912

510(k) Number K951912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1995
Decision Date May 12, 1995
Days to Decision 18 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 115d · This submission: 18d
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 1400
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K951912.
NEZHAT-DORESEY PENCIL-GRIP HANDLES
K951732 · American Hydro-Surgical Instruments, Inc. · May 1995
PRECISION BIPOLAR COAGULATOR
K951985 · Valley Forge Scientific Corp. · May 1995
NEZHAT-DORESY ELECTROSURGICAL HAND CONTROL ATTACHMENTS
K951731 · American Hydro-Surgical Instruments, Inc. · May 1995
MANUAL SURGICAL INSRUMENT
K951589 · United States Surgical, A Division of Tyco Healthc · May 1995
LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD
K951328 · Labeltape Meditect, Inc. · Apr 1995
DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL
K951269 · Boston Surgical Products, Inc. · Apr 1995