FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT

K Number: K873748 · Decision Jan 6, 1988
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
282
Applicant Total
37
Review Days
112

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Basic Information

Device Name
RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT
K Number
K873748
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4750
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Deknatel, Inc.
Date Received
September 16, 1987
Decision Date
January 6, 1988
Product Code
GDW
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GDW Staple, Implantable

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Other Clearances by Deknatel, Inc.

K Number Device Name
K963850 PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
K962683 SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR
K964070 DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG
K963098 PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)
K962856 PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
K925243 DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER
K930738 SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC
K930740 SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL
K930739 SUTURES POLYPROP., POLYETHELINE, NYLON & SILK
K926338 PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F
Search all 37 clearances from Deknatel, Inc. →