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510(k) K970382

VS-100 VIDEO SIGMOIDOSCOPE by Welch Allyn, Inc. — Product Code FAM

K970382 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "VS-100 VIDEO SIGMOIDOSCOPE". The FDA issued a decision of Substantially Equivalent on April 17, 1997. The device falls under product code FAM (Sigmoidoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Welch Allyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1997
Date Received
February 3, 1997
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 Welch Allyn, Inc.

  • K243598 — Welch Allyn Connex® 360 (Multiple) (July 13, 2025)
  • K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (December 20, 2024)
  • K223381 — iExaminer System with Panoptic Plus (March 15, 2023)
  • K212473 — Welch Allyn Connex Central Station (October 28, 2022)
  • K191013 — Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option (September 10, 2019)
  • K181016 — Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System (July 16, 2018)
  • K171621 — Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall Syste (June 30, 2017)
  • K142356 — Connex Spot Monitor,901058 Vital Signs Monitor Core (December 19, 2014)
  • K141582 — CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION (July 11, 2014)
  • K132807 — MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) (January 31, 2014)

Other clearances for product code FAM

  • K964131 — ENDOSCOPE (June 27, 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)
  • K951573 — FS-38H, FIBER SIGMOIDOSCOPE (June 27, 1995)

FDA data resources