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510(k) K971853

ENDOVIEW SPPHIRE LENS SET by American Medical Devices, Inc. — Product Code HJK

K971853 is an FDA 510(k) premarket notification submitted by American Medical Devices, Inc. for the device "ENDOVIEW SPPHIRE LENS SET". The FDA issued a decision of Substantially Equivalent on August 6, 1997. The device falls under product code HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic), a Class II device regulated under 21 CFR 886.1385. American Medical Devices, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1997
Date Received
May 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class
Class II
Regulation Number
886.1385
Review Panel
OP
Submission Type

Other clearances by American Medical Devices, Inc.

  • K974561 — MOISTAIR FLUID AIR TUBING SET (February 19, 1998)
  • K970882 — ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.) (June 24, 1997)
  • K970875 — ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) (May 20, 1997)
  • K970873 — ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) (May 20, 1997)
  • K970878 — ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT (May 6, 1997)

Other clearances for product code HJK

  • K201909 — RxSight Contact Lens (September 10, 2020)
  • K173944 — Endocular Viewing Lenses and Silicone Ring (October 25, 2018)
  • K151961 — Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens (August 18, 2015)
  • K142715 — Sensor Medical Family of Vitrectomy Lenses and Products (December 16, 2014)
  • K051630 — SUPER VIEW DISPOSABLE BIOM LENS SET (June 29, 2005)
  • K051103 — HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY (June 7, 2005)
  • K050623 — VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK (March 28, 2005)
  • K033950 — DORC VITRECTOMY LENSES, MODEL 1284 SERIES (February 20, 2004)
  • K030054 — DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES (February 26, 2003)
  • K023221 — CONTACT LASER & DIAGNOSTIC LENSES (October 11, 2002)

FDA data resources