FDA.reportPublic FDA data

Self-light anoscopes

Primary DI
08033638802861
Brand
Self-light anoscopes
Company
SAPI MED SPA
Model
Self-led-light diagnostic anoscope + Led light
Catalog number
A.4018L
Device description
SELF-LED-LIGHT - Diagnostic/pediatric beveled proctoscope with built-in LED light. Disposable. Tube length 54mm. Tube diameter 18mm.
Published
2026-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FERAnoscope And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FERAnoscope And AccessoriesGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070913000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070913000SELF-LIGHT DISPOSABLE ANOSCOPESapimed S.P.A.2007-08-10FER

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033638802878PackageGS125In Commercial Distribution
08033638802861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033638802878080336388028788033638802878
08033638802861080336388028618033638802861

GMDN Terms#

Term, Definition table
TermDefinition
Optical anoscope, single-useAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or direct vision. This device is typically used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. This is a single-use device.

Regulatory Flags#

DUNS number
437320088
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
08033638801710Self-Suction-LEMSelf-Suction-LEMA.56702026-02-06
08033638801727Self-Suction-LEMSelf-Suction-LEMA.56702026-02-06
08033638802878Self-light anoscopesSelf-led-light diagnostic anoscope + Led lightA.4018L2026-02-06
08033638800614Rectoscope equipmentRectoscope equipment with LED and insufflatorA.4513LINS2025-02-17
08033638800621Rectoscope equipmentRectoscope equipment with LED and insufflatorA.4513LINS2025-02-17
08033638801536Rectoscope equipmentRectoscope equipment with LED and insufflatorA.4520LINS2025-02-17
08033638800027AnoscopeA.4019A.40192016-11-25
08033638800041AnoscopeA.4023.1A.4023.12016-11-25
08033638800065AnoscopeA.4024.1A.4024.12016-11-25
08033638800089RetractorA.4081A.40812016-11-25
08033638800102RetractorA.4082A.40822016-11-25
08033638800126RetractorA.4083A.40832016-11-25
08033638800140RetractorA.4084A.40842016-11-30
08033638800164RectoscopeA.4113A.41132016-11-25
08033638800188RectoscopeA.4120A.41202016-11-25
08033638800201RectoscopeA.4125A.41252016-11-25
08033638800249RectoscopeA.4519A.45192016-11-25
08033638800263RectoscopeA.4522A.45222016-11-25
08033638800430Self-light anoscopesSELF-LIGHT SCOPEA.40222023-07-27
08033638800478Self-light anoscopesOperative Self-Led-Light A.4023.1L2023-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060937770013SleeveLUX 24 Anoscope/ProctoscopeHaemoband SurgicalFER2026-04-28
05060937770020SleeveLUX 16 Anoscope/ProctoscopeHaemoband SurgicalFER2026-04-28
08033638802878Self-light anoscopesSAPI MED SPAFER2026-02-06
00860012876808Air AssistGASTRO CONCEPTS LLCFER2025-03-17
08051887044719THD N-Ano anoscopesTHD SPAFER2025-03-14
08051887044733THD N-Ano anoscopeTHD SPAFER2025-03-14
08051887044757THD N-Ano AnoscopeTHD SPAFER2025-03-14
08051887044771THD N-ano anoscopeTHD SPAFER2025-03-14
18051887044730THD N-Ano anoscopeTHD SPAFER2025-03-14
18051887044754THD N-Ano AnoscopeTHD SPAFER2025-03-14
08033638801192AdaptorSAPI MED SPAFER2023-08-02
08033638800430Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638800478Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638800485Self-light anoscopesSAPI MED SPAFER2023-07-27
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08033638800447Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638803585Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638801260Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638801369EpoflierSAPI MED SPAFER2023-07-27
08033638802892Self-light anoscopesSAPI MED SPAFER2023-07-27
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00732094239331Welch Allyn, Inc.WELCH ALLYN, INC.FER2023-04-25
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