FDA.reportPublic FDA data

MiniSPC Button

Primary DI
00842071150006
Brand
MiniSPC Button
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
SPC-1412-24
Catalog number
SPC-1412-24
Device description
"14F x 1.2cm MiniSPC Low Profile Suprapubic Catheter with 24"" Drainage Set, MDR"
Published
2026-03-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)
KOBCatheter, Suprapubic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2
KOBCatheter, Suprapubic (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240514000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240514000AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc.2024-11-01KOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071150006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071150006008420711500068420711500060842071150006

GMDN Terms#

Term, Definition table
TermDefinition
Suprapubic drainage catheterA flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a patient for the drainage of urine; it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube with holes/tips at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion; however, it does not include non-dedicated supportive devices (i.e., not a kit). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge14French
Length1.2Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(440)717-4000cs@appliedmedical.net

Regulatory Flags#

DUNS number
038101861
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842071146634MINI Balloon Button5-18175-18172026-10-19
00842071146641MINI Balloon Button5-1817-I5-1817-I2026-10-19
00842071146672MINI Balloon Button5-18235-18232026-10-19
00842071146689MINI Balloon Button5-1823-I5-1823-I2026-10-19
00842071146696MINI Balloon Button5-18255-18252026-10-19
00842071146702MINI Balloon Button5-1825-I5-1825-I2026-10-19
00842071146719MINI Balloon Button5-18275-18272026-10-19
00842071146726MINI Balloon Button5-1827-I5-1827-I2026-10-19
00842071146733MINI Balloon Button5-18305-18302026-10-19
00842071146740MINI Balloon Button5-1830-I5-1830-I2026-10-19
00842071146757MINI Balloon Button5-18355-18352026-10-19
00842071146764MINI Balloon Button5-1835-I5-1835-I2026-10-19
00842071146771MINI Balloon Button5-18405-18402026-10-19
00842071146788MINI Balloon Button5-1840-I5-1840-I2026-10-19
00842071146979MINI Balloon Button5-20255-20252026-10-19
00842071146986MINI Balloon Button5-2025-I5-2025-I2026-10-19
00842071136383AMT Stiffener for Initial PlacementE4-6010E4-6010, 4-60102026-10-16
00842071145774MINI Balloon Button5-12105-12102026-10-09
00842071145781MINI Balloon Button5-1210-I5-1210-I2026-10-09
00842071146573MINI Balloon Button5-18105-18102026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071146634MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146641MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146672MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146689MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146696MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146702MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146719MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146726MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146733MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146740MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146757MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146764MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146771MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146788MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146979MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146986MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071136383AMT Stiffener for Initial PlacementAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-16
00350770997742MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTWAvanos Medical, Inc.KNT2026-10-14
00350770997759MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTWAvanos Medical, Inc.KNT2026-10-14
00350770997766MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTWAvanos Medical, Inc.KNT2026-10-14
00350770997773MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTWAvanos Medical, Inc.KNT2026-10-14
00350770997803MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997810MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997827MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997865MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997872MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997889MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997926MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997933MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997940MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-14