510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Acmi Corporation

Southborough, MA, US

Acmi Corporation appears in FDA device records in Southborough, MA. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
16
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 16 510(k) clearances for Acmi Corporation between 2002 and 2006. The busiest year on record is 2003, with 6. The most recent is 2006, with 3.

Clearances by year, as a table
510(k) clearance decisions for Acmi Corporation, by decision year
YearClearances
20022
20036
20042
20053
20063
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K061975PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PKGEISubstantially Equivalent
K060752ACMI DUR-HL LASER SYSTEMSGEXSubstantially Equivalent
K060269ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEMFBNSubstantially Equivalent
K051593UROPASS URETERAL ACCESS SHEATH, MODEL 61224KNYSubstantially Equivalent
K052044ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6ALFGBSubstantially Equivalent
K043581DUAL LUMEN CATHETEREYBSubstantially Equivalent
K042069INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEMGCJSubstantially Equivalent
K042225ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565FAJSubstantially Equivalent
K031758ACMI M4 TELESCOPESFBPSubstantially Equivalent
K030960ECN ELECTRONIC VIDEO CYSTONEPHROSCOPEFAJSubstantially Equivalent
K030935BERKELEY V-10 VACUUM CURETTAGE SYSTEMHHISubstantially Equivalent
K030684SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SHOCUSubstantially Equivalent
K031001ACMI VISTA CTR BIPOLAR LOOP ELECTRODEFASSubstantially Equivalent
K023358USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8FGBSubstantially Equivalent
K022480ACMI DISPOSABLE BIPOLAR CORD, MODEL DBCHIHSubstantially Equivalent
K012018BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910GEISubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain