FDA.reportPublic FDA data

NA

Primary DI
10810003224818
Brand
NA
Company
MICROSPECIALITIES, INC.
Model
MK8508
Device description
ACCUBLADE (HANSATOME MODEL)
Published
2026-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNOKeratome, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNOKeratome, Ac-PoweredOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994015000ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508Surgin Surgical Instrumentation, Inc.2000-03-15HNO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30810003224812PackageGS110In Commercial Distribution
10810003224818PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081000322481230810003224812
1081000322481810810003224818

GMDN Terms#

Term, Definition table
TermDefinition
Keratome blade, single-useA surgical cutting device with a very sharp edge that is designed to be mounted into a keratome and is used to shave tissue from sections of the cornea. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
203-874-1832info@microspecialties.com

Regulatory Flags#

DUNS number
013469890
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810003224757NAMK8510LSKMK8510LSK2026-04-29
10810003224764NAMK8511CB2026-04-29
10810003224771NA3001352026-04-29
10810003224788NA3001602026-04-29
10810003224795NA300202026-04-29
10810003224801NAMK85072026-04-29
10810003223545Comfortear™24-200824-20082019-01-03
10810003223552Comfortear™24-200724-20072019-01-03
10810003223569Comfortear™24-200624-20062019-01-03
10810003223576Comfortear™24-200524-20052019-01-03
10810003223583Comfortear™24-200424-20042019-01-03
10810003223590Comfortear™32-200832-20082019-01-03
10810003223606Comfortear™32-200732-20072019-01-03
10810003223613Comfortear™32-200632-20062019-01-03
10810003223620Comfortear™32-200532-20052019-01-03
10810003223637Comfortear™32-200432-20042019-01-03
10810003223644Comfortear™60-601060-60102019-01-03
10810003224443Pro-Paks1002PL1002PL2023-09-02
10810003224450Pro-Paks2002PL2002PL2023-09-02
10810003224467Pro-PaksES BasicES Basic2023-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810003224757NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224764NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224771NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224788NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224795NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224801NAMICROSPECIALITIES, INC.HNO2026-04-29
00380650004529Wave Light FS200 EASYPACKAlcon Laboratories, Inc.HNO2025-11-20
03700483603121MORIAMORIA SAHNO2024-05-07
03700483603145MORIAMORIA SAHNO2024-05-07
03700483603169MORIAMORIA SAHNO2024-05-07
03700483603183MORIAMORIA SAHNO2024-05-07
03700483603206MORIAMORIA SAHNO2024-05-07
03700483603220MORIAMORIA SAHNO2024-05-07
03700483603244MORIAMORIA SAHNO2024-05-07
03700483603374MORIAMORIA SAHNO2024-05-07
03700483603398MORIAMORIA SAHNO2024-05-07
03700483603930MORIAMORIA SAHNO2024-05-07
03700483603954MORIAMORIA SAHNO2024-05-07
03700483603138MORIAMORIA SAHNO2024-05-07
03700483603152MORIAMORIA SAHNO2024-05-07
03700483603176MORIAMORIA SAHNO2024-05-07
03700483603190MORIAMORIA SAHNO2024-05-07
03700483603213MORIAMORIA SAHNO2024-05-07
03700483603237MORIAMORIA SAHNO2024-05-07
03700483603251MORIAMORIA SAHNO2024-05-07
03700483603381MORIAMORIA SAHNO2024-05-07
03700483603404MORIAMORIA SAHNO2024-05-07
03700483603947MORIAMORIA SAHNO2024-05-07
03700483603961MORIAMORIA SAHNO2024-05-07
04049471110142Treatment Pack (Size M)Carl Zeiss Meditec AGHNO2024-02-09