510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MARKET-TIERS, Inc. d/b/a Blue Endo

Lenexa, KS, US

MARKET-TIERS, INC. d/b/a Blue Endo appears in FDA device records in Lenexa, KS. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to MARKET-TIERS, Inc. d/b/a Blue Endo carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Market-Tiers, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for MARKET-TIERS, Inc. d/b/a Blue Endo in 1994.

Clearances by year, as a table
510(k) clearance decisions for MARKET-TIERS, Inc. d/b/a Blue Endo, by decision year
YearClearances
19941
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K932617S*E*M*M-SET & C*U*R*T-SETGCJSubstantially Equivalent

Registered establishments

FDA registered establishments for MARKET-TIERS, Inc. d/b/a Blue Endo, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
19329651000219003MARKET-TIERS, INC. d/b/a Blue Endo8097 Flint St, Lenexa, KS 66214 US2026No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2145-2014Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.Class IITerminated

Verification record

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