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510(k) K771181

VAGINAL ILLUMINATOR, MODEL 78570 by Welch Allyn, Inc. — Product Code HDG

K771181 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "VAGINAL ILLUMINATOR, MODEL 78570". The FDA issued a decision of Substantially Equivalent on July 14, 1977. The device falls under product code HDG (Speculum, Vaginal, Metal, Fiberoptic), a Class I device regulated under 21 CFR 884.4520. Welch Allyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1977
Date Received
June 30, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Vaginal, Metal, Fiberoptic
Device Class
Class I
Regulation Number
884.4520
Review Panel
OB
Submission Type

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 HDG

  • K864865 — SPECULUM, VAGINAL, METAL FIBEROPTIC (January 9, 1987)

FDA data resources