Atlas FDA

ENTERON ABDOMINAL PARACENTESIS TRAY

FDA 510(k) clearance K874063 · decided 1987-12-04

Clearance details

K-number
K874063
Device name
ENTERON ABDOMINAL PARACENTESIS TRAY
Applicant
Endovations
Decision
Unknown
Date received
1987-10-05
Decision date
1987-12-04
Days to decision
60 days
Clearance type
Traditional
Product code
KDD
Device class
1
Regulation number
878.4800
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Camp Hill, PA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES (K072814)Covidien2008-04-16
INSTRUMENTS FOR ONE TIME USE - DISPOSABLE (K011514)Kencap , Ltd.2001-08-13
NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (K971317)National Healthcare Mfg. Corp.1997-05-08
DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY (K960456)Denver Biomaterials, Inc.1996-04-01
CUSTOM CV PACK (K936255)Associated Medical1994-03-31
SUTURE SET OR LACERATION TRAYS (PACKS) (K932219)Associated Medical Products Co.1993-07-09
SURGICAL INSTRUMENT KIT, DISPOSABLE (K923176)Ulti-Med Intl., Inc.1993-06-17
KIT, SURGICAL INSTRUMENT, DISPOSABLE (K925905)Kay Medical Concepts1993-06-16
BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY (K924958)Medical Insights, Inc.1993-06-07
STERILE SURGICAL INSTRUMENT TRAYS (K925215)American Healthcare Supply Co., Inc.1993-06-01
DEXIDE LAPAROSCOPIC KITS (K924117)Dexide, Inc.1993-03-23
SURGICAL INSTRUMENT KIT, DISPOSABLE (K920989)Ulti-Med Intl., Inc.1992-10-19

Recalls involving this device

RecordFirmDate
Description/REF: PARACENTESIS KIT/ASK-00376-JHH recall (Z-2386-2026)ARROW INTERNATIONAL, LLC2026-06-13