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510(k) K884057

ELAN-E DISPOSABLE DRAPE by Aesculap Instruments Corp. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1988
Date Received
September 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Aesculap Instruments Corp.

  • K890182 — PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV (February 28, 1990)
  • K885046 — INSITUCAT VALVE STRIPPER (February 28, 1990)
  • K890443 — CASPAR SCALP CLIP, APPLIER (June 15, 1989)
  • K893121 — ROBOTRAC (TM) RETRACTOR ARM (June 1, 1989)
  • K880704 — CERULLO SUCTION REGULATOR (March 29, 1988)
  • K860016 — AESCULAP BONE MILL (March 19, 1986)
  • K801888 — HANDPIECE, DENTAL (August 20, 1980)
  • K801886 — BURR, DENTAL (August 20, 1980)
  • K801887 — DRILL, DENTAL (August 20, 1980)
  • K792558 — CONTAINER SYSTEM (December 27, 1979)

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  • K200238 — ControlRad Sterile Cover (April 26, 2020)
  • K163556 — MediClear PreOp (September 14, 2017)
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  • K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
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  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)