Cleared Traditional

K972749 - PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)

K972749 is an FDA 510(k) clearance for PAO BIPOLAR COAXIAL COAGULATOR (55-P15C..., manufactured by C.M. Chance , Ltd.. The device is a Class 2 Ophthalmic device with product code HQR cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K972749 · C.M. Chance , Ltd. · Ophthalmic device
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Mar 1998
Decision
233d
Days
Class 2
Risk

K972749 is an FDA 510(k) clearance for the PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S). Classified as Apparatus, Cautery, Radiofrequency, Ac-powered (product code HQR), Class II - Special Controls.

Submitted by C.M. Chance , Ltd. (Southampton, US). The FDA issued a Cleared decision on March 13, 1998 after a review of 233 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4100 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all C.M. Chance , Ltd. devices

FDA 510(k) Submission Details - K972749

510(k) Number K972749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1997
Decision Date March 13, 1998
Days to Decision 233 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
123d slower than avg
Panel avg: 110d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQR Device Classification - Class 2, Special Controls

Product Code HQR Apparatus, Cautery, Radiofrequency, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4100
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.