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FDA 510(k)

SURG-K SURGICAL KERATOMETER

K-Number: K901553 · 1990-07-20

ApplicantThe Sanborn Co.
Decision Date1990-07-20
Product CodeHLR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SURG-K SURGICAL KERATOMETER is the device name listed in this FDA 510(k) record. The listed applicant is The Sanborn Co.. It received FDA 510(k) clearance on 1990-07-20 under 510(k) number K901553. The device is classified under product code HLR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURG-K SURGICAL KERATOMETER?

SURG-K SURGICAL KERATOMETER is a medical device that received FDA 510(k) clearance on 1990-07-20. The listed applicant is The Sanborn Co.. The 510(k) number is K901553.

When did SURG-K SURGICAL KERATOMETER receive FDA 510(k) clearance?

SURG-K SURGICAL KERATOMETER received FDA 510(k) clearance on 1990-07-20, under 510(k) number K901553.

Who is the listed applicant for SURG-K SURGICAL KERATOMETER?

The FDA 510(k) record lists The Sanborn Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURG-K SURGICAL KERATOMETER?

The FDA product code for SURG-K SURGICAL KERATOMETER is HLR.

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 The Sanborn Co. 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.

K901523VKG 1000, VIDEO KERATOGRAPH

Related Devices (Code: HLR)

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.

K882902QRK 100, QUALITATIVE RING KERATOSCOPETechnitex, Inc.K882618JEDMED/POLACK KERATOSCOPE HS/SLGamut Ent.K864639REUSABLE SURGICAL KERATOSCOPEJedmed Instrument Co.K854054PLACIDO DISCCutler Medical InstrumentsK830008KARICKHOFF KERATOSCOPESurgidev Corp.K821080HAND KERATOSCOPEMedical Equipment Designs, 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.

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