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510(k) K964131

ENDOSCOPE by Akos Biomedical, Inc. — Product Code FAM

K964131 is an FDA 510(k) premarket notification submitted by Akos Biomedical, Inc. for the device "ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on June 27, 1997. The device falls under product code FAM (Sigmoidoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1997
Date Received
October 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sigmoidoscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

to examine and perform procedures within the sigmoid (descending) colon

Other clearances for product code FAM

  • K970382 — VS-100 VIDEO SIGMOIDOSCOPE (April 17, 1997)
  • K964326 — VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH (January 3, 1997)
  • K964100 — VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FI (December 16, 1996)
  • K963344 — DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOID (November 21, 1996)
  • K961567 — ES-3840, VIDEO SIGMOIDOSCOPE (June 24, 1996)
  • K951577 — ES-3800, VIDEO SIGMOIDOSCOPE (March 21, 1996)
  • K950429 — VIDEO SIGMOIDOSCOPE (August 1, 1995)
  • K951576 — FS-34P2, FIBER SIGMOIDOSCOPE (June 29, 1995)
  • K951573 — FS-38H, FIBER SIGMOIDOSCOPE (June 27, 1995)
  • K951572 — FS-38X, FIBER SIGMOIDOSCOPE (June 27, 1995)

FDA data resources