Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

POLLY'S CUTTER J-225

K-Number: K914038 · 1991-12-09

ApplicantO.R. Specialties, Inc.
Decision Date1991-12-09
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

POLLY'S CUTTER J-225 is the device name listed in this FDA 510(k) record. The listed applicant is O.R. Specialties, Inc.. It received FDA 510(k) clearance on 1991-12-09 under 510(k) number K914038. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLLY'S CUTTER J-225?

POLLY'S CUTTER J-225 is a medical device that received FDA 510(k) clearance on 1991-12-09. The listed applicant is O.R. Specialties, Inc.. The 510(k) number is K914038.

When did POLLY'S CUTTER J-225 receive FDA 510(k) clearance?

POLLY'S CUTTER J-225 received FDA 510(k) clearance on 1991-12-09, under 510(k) number K914038.

Who is the listed applicant for POLLY'S CUTTER J-225?

The FDA 510(k) record lists O.R. Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLLY'S CUTTER J-225?

The FDA product code for POLLY'S CUTTER J-225 is HQE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing O.R. Specialties, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K942607LAPAROSCOPIC SCISSORS (DISPOSABLE)K923630PHACO NEEDLES 1000-R & 1000-O NEEDLESK925671DISPOSABLE SCLERAL PLUGSK923887JACK'S VENT TUBESK923774DISPOSABLE ENDOILLUMINATORK922355POLLY'S VITREOUS SCISSORS J-225-S

View all 14 devices →

Related Devices (Code: HQE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑