Cleared Traditional

K862709 - MECHANICAL CYSTITOME

K862709 is an FDA 510(k) clearance for MECHANICAL CYSTITOME, manufactured by Rudolph Beaver, Inc.. The device is a Class 1 Ophthalmic device with product code HNY cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K862709 · Rudolph Beaver, Inc. · Ophthalmic device
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Aug 1986
Decision
16d
Days
Class 1
Risk

K862709 is an FDA 510(k) clearance for the MECHANICAL CYSTITOME. Classified as Cystotome (product code HNY), Class I - General Controls.

Submitted by Rudolph Beaver, Inc. (Waltham, US). The FDA issued a Cleared decision on August 1, 1986 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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 Rudolph Beaver, Inc. devices

FDA 510(k) Submission Details - K862709

510(k) Number K862709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1986
Decision Date August 01, 1986
Days to Decision 16 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 110d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

HNY Device Classification - Class 1, General Controls

Product Code HNY Cystotome
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HNY Cystotome

All 10
Devices cleared under the same product code (HNY) and FDA review panel - the closest regulatory comparables to K862709.
PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME
K874997 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME
K875001 · Advanced Surgical Products, Inc. · Apr 1988
LOOK IRRIGATING CYSTOTOMES
K870439 · Look, Inc. · Feb 1987
DISPOSABLE CYSTOTOME
K831916 · CooperVision, Inc. · Jul 1983
CYSTOTOMES
K790244 · Visitec Co. · Feb 1979