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FDA 510(k)

ENDOVIEW SPPHIRE LENS SET

K-Number: K971853 · 1997-08-06

ApplicantAmerican Medical Devices, Inc.
Decision Date1997-08-06
Product CodeHJK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ENDOVIEW SPPHIRE LENS SET is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Devices, Inc.. It received FDA 510(k) clearance on 1997-08-06 under 510(k) number K971853. The device is classified under product code HJK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOVIEW SPPHIRE LENS SET?

ENDOVIEW SPPHIRE LENS SET is a medical device that received FDA 510(k) clearance on 1997-08-06. The listed applicant is American Medical Devices, Inc.. The 510(k) number is K971853.

When did ENDOVIEW SPPHIRE LENS SET receive FDA 510(k) clearance?

ENDOVIEW SPPHIRE LENS SET received FDA 510(k) clearance on 1997-08-06, under 510(k) number K971853.

Who is the listed applicant for ENDOVIEW SPPHIRE LENS SET?

The FDA 510(k) record lists American Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOVIEW SPPHIRE LENS SET?

The FDA product code for ENDOVIEW SPPHIRE LENS SET is HJK.

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Other records listing American Medical Devices, 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.

K974561MOISTAIR FLUID AIR TUBING SETK970882ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)K970875ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)K970873ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)K970878ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT

Related Devices (Code: HJK)

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.

K201909RxSight Contact LensRxsight, Inc.K173944Endocular Viewing Lenses and Silicone RingPhakosK051630SUPER VIEW DISPOSABLE BIOM LENS SETInsight Instruments, Inc.K051103HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORYHaag-Streit USA, Inc.K050623VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV DVolk Optical, Inc.K033950DORC VITRECTOMY LENSES, MODEL 1284 SERIESDutch Ophthalmic Research Center (D.O.R.C.)

Official Source

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

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