Cleared Traditional

K943031 - BIPOLAR ELECTROSURGICAL PENCIL

K943031 is an FDA 510(k) clearance for BIPOLAR ELECTROSURGICAL PENCIL, manufactured by Boston Surgical Products, Inc.. The device is a Class 2 Ophthalmic device with product code HQO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K943031 · Boston Surgical Products, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
88d
Days
Class 2
Risk

K943031 is an FDA 510(k) clearance for the BIPOLAR ELECTROSURGICAL PENCIL. Classified as Unit, Cautery, Thermal, Ac-powered (product code HQO), Class II - Special Controls.

Submitted by Boston Surgical Products, Inc. (Kingston, US). The FDA issued a Cleared decision on September 23, 1994 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4115 - the FDA ophthalmic 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 - K943031

510(k) Number K943031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1994
Decision Date September 23, 1994
Days to Decision 88 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 110d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQO Device Classification - Class 2, Special Controls

Product Code HQO Unit, Cautery, Thermal, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4115
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 Ophthalmic devices follow this clearance model.