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510(k) K822765

SIGMOIDOSCOPE, FLEXIBLE by Harvard Laboratories — Product Code FAM

K822765 is an FDA 510(k) premarket notification submitted by Harvard Laboratories for the device "SIGMOIDOSCOPE, FLEXIBLE". The FDA issued a decision of Substantially Equivalent on November 17, 1982. The device falls under product code FAM (Sigmoidoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Harvard Laboratories has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1982
Date Received
September 14, 1982
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 Harvard Laboratories

  • K810573 — TUBE FEEDING SET (April 23, 1981)
  • K810574 — SUCTION COLLECTION BOTTLE, DISPOSABLE (April 21, 1981)
  • K800877 — ANESTHESIA EXTENSION TUBES (June 17, 1980)
  • K800878 — SECONDARY I.V. TUBING SETS (June 17, 1980)
  • K800879 — CLEAR PLASTIC CONNECTING TUBES (June 17, 1980)
  • K800880 — PLASTIC TUBING ADAPTERS 5-IN-1- (May 14, 1980)
  • K800881 — DISPOSABLE BERMAN AIRWAYS (May 8, 1980)

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