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510(k) K964123

REUSABLE TROCAR WITH SLEEVE (COMMON) by Pilling Weck Group — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1996
Date Received
October 15, 1996
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 Pilling Weck Group

  • K971334 — PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR (June 11, 1997)
  • K965176 — PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS (March 4, 1997)
  • K964450 — SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT (January 10, 1997)
  • K963815 — REUSABLE TROCAR WITH SLEEVE (COMMON) (November 5, 1996)

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