Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Aesculap Caiman 12 Seal and Cut Technology System

K-Number: K203461 · 2020-12-18

ApplicantAesculap, Inc.
Decision Date2020-12-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aesculap Caiman 12 Seal and Cut Technology System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2020-12-18 under 510(k) number K203461. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aesculap Caiman 12 Seal and Cut Technology System?

Aesculap Caiman 12 Seal and Cut Technology System is a medical device that received FDA 510(k) clearance on 2020-12-18. The listed applicant is Aesculap, Inc.. The 510(k) number is K203461.

When did Aesculap Caiman 12 Seal and Cut Technology System receive FDA 510(k) clearance?

Aesculap Caiman 12 Seal and Cut Technology System received FDA 510(k) clearance on 2020-12-18, under 510(k) number K203461.

Who is the listed applicant for Aesculap Caiman 12 Seal and Cut Technology System?

The FDA 510(k) record lists Aesculap, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aesculap Caiman 12 Seal and Cut Technology System?

The FDA product code for Aesculap Caiman 12 Seal and Cut Technology System is GEI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITINGNCT05281757Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® ComplexRECRUITINGNCT05296889Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® CervicalRECRUITINGNCT05433688Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass SurgeryCOMPLETEDNCT05813236NOVOSYN® Quick Versus MONOSYN® Quick Suture Material in Resective Periodontal SurgeryRECRUITINGNCT06024109Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total HysterectomyRECRUITING

Other records listing Aesculap, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242762Aesculap Aicon® Series Container SystemK242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetK223596SQ.line KERRISONK214041Aesculap AICON ContainerK211572Aesculap Slim Clip ApplierK203739ELAN 4 Electro Motor System

View all 34 devices →

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑