Home / 510(k) Clearances / K812965

510(k) K812965

MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE by American Optical Corp. — Product Code FAM

K812965 is an FDA 510(k) premarket notification submitted by American Optical Corp. for the device "MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE". The FDA issued a decision of Substantially Equivalent on November 2, 1981. The device falls under product code FAM (Sigmoidoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. American Optical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1981
Date Received
October 22, 1981
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 by American Optical Corp.

  • K950881 — PHACO TIP (September 6, 1995)
  • K950880 — AOI UNIVERSAL ULTRASONIC HANDPIECE (May 26, 1995)
  • K931354 — P4000 PHACOEMULSIFIER (February 22, 1994)
  • K931358 — AORP4000 REUSABLE PAK (February 22, 1994)
  • K931357 — AOD4000 DISPOSABLE PAK (January 25, 1994)
  • K820790 — FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 (April 1, 1982)
  • K813430 — TISSUE PROCESSING CASSETTES & ACCESS (December 29, 1981)
  • K812051 — PHOTOLITE AOLITE TINTOMATIC LENS (September 8, 1981)
  • K812063 — SR-1V DATA PRINTER (August 18, 1981)
  • K811535 — MODEL FUS-1, FLEXIBLE URETEROSCOPE (June 23, 1981)

Other clearances for product code FAM

  • K964131 — ENDOSCOPE (June 27, 1997)
  • 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)
  • K951572 — FS-38X, FIBER SIGMOIDOSCOPE (June 27, 1995)

FDA data resources