Atlas FDA

BONE MARROW ASPIRATION KIT

FDA 510(k) clearance K781371 · decided 1978-09-20

Clearance details

K-number
K781371
Device name
BONE MARROW ASPIRATION KIT
Applicant
Ferris Mfg. Corp.
Decision
Substantially Equivalent
Date received
1978-08-08
Decision date
1978-09-20
Days to decision
43 days
Clearance type
Traditional
Product code
GAA
Device class
1
Regulation number
878.4800
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Mchenry, IL, 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
CapnoSpot™ Pneumothorax Decompression Indicator (K223625)Pneumeric, Inc.2023-03-28
ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT (K102274)Arvik Enterprises/ Mini Lap Technologies2011-06-15
IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE (K011586)Diametrics Medical, Inc.2001-11-16
PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES (K994151)Ximed/Prosure/Injectx2000-03-01
INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX (K983200)Ximed/Prosure/Injectx1998-12-11
MANAN ACCURA NEEDLE (K974741)Medical Device Technologies, Inc.1998-01-08
BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) (K962425)Radi Medical Systems AB1996-09-11
MD TECH BIOPSY SET FOR BONE AND BONE MARROW (K961959)Medical Device Technologies, Inc.1996-07-19
MONOJECT BONE MARROW BIOPSY TRAYS (K945109)Sherwood Medical Co.1994-11-14
MANAN BONE MARROW HARVEST NEEDLES (K940025)Manan Medical Products, Inc.1994-02-25
MANAN GENERAL PURPOSE INTRODUCER NEEDLE (K940024)Manan Medical Products, Inc.1994-02-25
BONE MARROW BIOPSY PROCEDURE TRAY (K930158)Symbiosis Corp.1993-07-02

Recalls involving this device

No recalls on record reference this clearance.