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510(k) K951974

IMAGYN ENDOSCOPE SHEATH by Imagyn Medical, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1995
Date Received
April 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, General & Plastic Surgery
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Imagyn Medical, Inc.

  • K972426 — MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH (September 23, 1997)
  • K970750 — MICROSPAN INSEMINATION SYSTEM (May 5, 1997)
  • K971255 — IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER (April 21, 1997)
  • K965055 — IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES (March 6, 1997)
  • K963580 — IMAGYN FALLOPOSCOPY SYSTEM (January 31, 1997)
  • K961688 — MICROSPAN HYSTEROSCOPE (October 15, 1996)
  • K961506 — MICROSPAN HYSTEROSCOPE SHEATH (July 3, 1996)
  • K952032 — IMAGYN HYSTEROSCOPE SHEATHS (October 31, 1995)
  • K951996 — IMAGYN ENDOSCOPE (September 1, 1995)
  • K953201 — IMAGYN UROSCOPE (August 2, 1995)

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