Cleared Traditional

K972506 - INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR

K972506 is an FDA 510(k) clearance for INFINITECH BULLET ENDO ILLUMINATED PICK..., manufactured by Infinitech, Inc.. The device is a Class 2 Ophthalmic device with product code HJM cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K972506 · Infinitech, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
90d
Days
Class 2
Risk

K972506 is an FDA 510(k) clearance for the INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR. Classified as Transilluminator, Ac-powered (product code HJM), Class II - Special Controls.

Submitted by Infinitech, Inc. (Chesterfield, US). The FDA issued a Cleared decision on October 1, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1945 - 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 Infinitech, Inc. devices

FDA 510(k) Submission Details - K972506

510(k) Number K972506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1997
Decision Date October 01, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJM Device Classification - Class 2, Special Controls

Product Code HJM Transilluminator, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1945
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.

Regulatory Peers - HJM Transilluminator, Ac-powered

Devices cleared under the same product code (HJM) and FDA review panel - the closest regulatory comparables to K972506.
PEREGRINE DIFFUSION LIGHT PIPE
K950529 · Peregrine Surgical , Ltd. · Jun 1995
HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE
K931072 · Hgm, Inc. · Nov 1994
DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS)
K933445 · Storz Instrument Co. · Sep 1994
PEREGRINE WIDE ANGLE LIGHT PIPE
K940393 · Peregrine Surgical , Ltd. · Sep 1994
FIBEROPTIC ILLUMINATED INSTRUMENTS
K934269 · Visitec Co. · May 1994
VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)
K893170 · Keeler Instruments, Inc. · Jun 1989