ClearanceBrief
Panels › Gastroenterology, Urology › Product code KNQ · Class 2

Dilator, Esophageal

Regulation 876.5365

0510(k)s in 12 months (40 all time)
4recalls in 12 months (21 all time)
17recalls that name a 510(k)
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Top companies in KNQ

DateFirm and productCodeLinked 510(k)
Apr 23, 2026Diversatek Healthcare
Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
Open, Classified
KNQNone listed
Apr 23, 2026Diversatek Healthcare
Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
Open, Classified
KNQNone listed
Apr 23, 2026Diversatek Healthcare
Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
Open, Classified
KNQNone listed
Apr 23, 2026Diversatek Healthcare
Diversatek Healthcare Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
Open, Classified
KNQNone listed
Jul 10, 2013Boston Scientific Corporation
RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated f
Terminated
KNQK050232
Jun 19, 2007Conmed Endoscopic Technologies, Inc.
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr), length 4cm; product code/end item #000861 and #000867 (5 pack); Single Use, Non-Sterile; distributed by Co
Terminated
KNQK033936
Jun 19, 2007Conmed Endoscopic Technologies, Inc.
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr), length 4cm; product code/end item #000849 and #000859 (5 pack); Single Use, Non-Sterile; distributed by Co
Terminated
KNQK033936
Jun 19, 2007Conmed Endoscopic Technologies, Inc.
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr), length 4cm; product code/end item #000848 and #000858 (5 pack); Single Use, Non-Sterile; distributed by Co
Terminated
KNQK033936
Jun 19, 2007Conmed Endoscopic Technologies, Inc.
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 4cm; product code/end item #000847 and #000857 (5 pack); Single Use, Non-Sterile; distributed by Co
Terminated
KNQK033936
Jun 19, 2007Conmed Endoscopic Technologies, Inc.
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 4cm; product code/end item #000846; Single Use, Non-Sterile; distributed by ConMed Endoscopic Techn
Terminated
KNQK033936
Jun 19, 2007Conmed Endoscopic Technologies, Inc.
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 4cm; product code/end item #000845; Single Use, Non-Sterile; distributed by ConMed Endoscopic Techno
Terminated
KNQK033936
Jun 19, 2007Conmed Endoscopic Technologies, Inc.
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 6mm (18 Fr), length 4cm; product code/end item #000844; Single Use, Non-Sterile; distributed by ConMed Endoscopic Techno
Terminated
KNQK033936
Jun 19, 2007Conmed Endoscopic Technologies, Inc.
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr), length 8cm; product code/end item #000380 and #000379 (5 pack); Single Use, Non-Sterile; distributed by ConMed
Terminated
KNQK033936
Jun 19, 2007Conmed Endoscopic Technologies, Inc.
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr), length 8cm; product code/end item #000345 and #000736 (5 pack); Single Use, Non-Sterile; distributed by ConMed
Terminated
KNQK033936
Jun 19, 2007Conmed Endoscopic Technologies, Inc.
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr), length 8cm; product code/end item #000344 and #000735 (5 pack); Single Use, Non-Sterile; distributed by ConMed
Terminated
KNQK033936
Jun 19, 2007Conmed Endoscopic Technologies, Inc.
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 8cm; product code/end item #000343 and #000443 (5 pack); Single Use, Non-Sterile; distributed by ConMed
Terminated
KNQK033936
Jun 19, 2007Conmed Endoscopic Technologies, Inc.
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 8cm; product code/end item #000342; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologi
Terminated
KNQK033936
Jun 19, 2007Conmed Endoscopic Technologies, Inc.
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 8cm; product code/end item #000341; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologie
Terminated
KNQK033936
Feb 22, 2007Cook Endoscopy
Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
Terminated
KNQK935094
Jan 25, 2006Cook Endoscopy
SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable
Terminated
KNQK851955
Oct 15, 2003Wilson-Cook Medical Inc
Quantum TTC Biliary Balloon Dilator
Terminated
KNQK935094

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